EDAN SE-300A 3-Channel Electrocardiograph (Monochrome Screen)

The EDAN SE-300A is a compact, portable 3-channel resting electrocardiograph designed for routine 12-lead ECG acquisition in hospitals, clinics, and primary care settings. It is the monochrome-screen configuration within the SE-300 series, sharing the simultaneous 12-lead acquisition, integrated thermal printing, and battery-backed portability of the platform, with a 320 × 240-dot single-color LCD for waveform preview.

The SE-300A is FDA-cleared as part of the SE-3/SE-300 series under 510(k) K091513 (July 24, 2009) , with the model explicitly listed in the clearance for the SMART ECG Series Electrocardiograph. A subsequent clearance under K171943 (September 25, 2017) covers the SE-3 Series, including SE-3, SE-300A, SE-300B, and SE-301. The cleared intended use covers acquisition of ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrodes, for use in hospitals or healthcare facilities by doctors and trained healthcare professionals, to help users analyze and diagnose heart disease. The ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. The FDA summary for K171943 states “No clinical data”; evidence consisted of non-clinical bench testing (biocompatibility, electrical safety, EMC, performance per IEC 60601-2-25) and ECG interpretation features validated via database testing.

The SE-300A acquires all 12 leads simultaneously, then outputs 3-channel reports on an integrated thermal dot-matrix printer using 80 mm × 20 m rolled or 80 × 70 mm × 200-page Z-fold paper. Recording modes include AUTO, MANUAL, RHYTHM, USBPRT, and OFF, with selectable sensitivity (2.5/5/10/20 mm/mV, AGC) and paper speeds (5–50 mm/s). Pacemaker detection is available with the optional DE12 ECG board, which also enables 24-bit A/D resolution.

Power is supplied by AC mains (100–115 V / 220–240 V, 50/60 Hz) or a built-in rechargeable lithium-ion battery (14.8 V) , with approximately 6.5 hours of normal operation, about 3 hours of continuous recording in Manual mode, and up to 330 AUTO reports per charge. Internal storage holds 500 ECG records, with data transfer via Ethernet, RS232, or USB and PDF, DICOM, SCP, and XML report formats where configured.

The SE-300A is Class I with internal power supply, Type CF, defibrillation-proof, designed to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-25 standards, and CE marked as a Class IIa device under MDD 93/42/EEC. It also holds China NMPA registration covering the SE-300A model.

The SE-300A is built for facilities that need an FDA-cleared, CE-marked 3-channel ECG device with simultaneous 12-lead acquisition, a monochrome preview display, integrated thermal printing, and battery-backed portability—without the color screen of the SE-300B configuration.

Key Features & Benefits

Monochrome LCD for Waveform Preview

The 320 × 240-dot single-color LCD displays the ECG waveform in real time before recording, allowing the clinician to confirm signal quality, electrode contact, and baseline stability at the point of acquisition. The screen folds down when not in use, reducing the device footprint during transport and storage.

Simultaneous 12-Lead Acquisition with 3-Channel Output

The SE-300A acquires all 12 leads simultaneously through body surface electrodes, then presents and prints them as 3-channel reports. The full 12-lead set is captured in one acquisition pass, while the printed format remains manageable on 80 mm thermal paper. Lead selection and rhythm lead are user-configurable from any of the 12 standard leads.

Built-In Thermal Dot-Matrix Printer

The integrated thermal printer produces 3-channel ECG recordings on 80 mm × 20 m rolled or 80 × 70 mm × 200-page Z-fold paper, with selectable paper speeds of 5, 6.25, 10, 12.5, 25, or 50 mm/s (±3%). The printer is part of the main unit, so acquisition and hard-copy documentation happen in a single step.

Five Recording Modes for Flexible Workflow

The SE-300A supports AUTO, MANUAL, RHYTHM, USBPRT, and OFF modes, allowing the user to choose between pre-configured acquisition sequences, full manual control, rhythm strips, direct USB printing, and standby. This flexibility supports both experienced ECG technicians and staff who perform ECGs intermittently.

Selectable Filters and Optional Pacemaker Detection

The SE-300A applies AC filtering (on/off) and EMG filtering (25/35/45 Hz/off) , alongside DFT and low-pass filtering per the SE-300 series platform, to support trace readability across different recording environments. Pacemaker detection is available with the optional DE12 ECG board, which also upgrades A/D resolution to 24-bit.

SEMIP Interpretation with Advisory Labeling

The SE-300A includes automatic ECG measurements and interpretation, processed by the SEMIP algorithm (V1.7 or V1.8). Per the cleared labeling under K091513 / K171943, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only—it supports, but does not replace, clinician analysis and diagnosis. The FDA summary confirms ECG interpretation features were validated via database testing.

500 ECG Internal Storage with Multi-Interface Export

The SE-300A stores up to 500 ECG records internally, with data transfer to a PC via Ethernet, RS232, or USB. Reports can be exported in PDF, DICOM, SCP, and XML formats where the corresponding software options are configured.

Rechargeable Li-Ion Battery with AC/DC Power

The built-in rechargeable lithium-ion battery (14.8 V, 2200–2500 mAh) supports approximately 6.5 hours of normal operation, about 3 hours of continuous recording in Manual mode, and up to 330 AUTO reports per charge. The device can also run on AC mains (100–115 V / 220–240 V, 50/60 Hz), with automatic switching between power sources.

Safety Classification: Class I, Type CF, Defibrillation-Proof

The SE-300A is classified as Class I with internal power supply, Type CF (defibrillation-proof applied part) under IEC 60601-1. The patient connection is fully isolated, and the device is defibrillation-proof, supporting use in settings where defibrillation may occur.

Technical Specifications

Why Choose the EDAN SE-300A?